Quality Assurance Manager
The Quality Assurance Manager India and South Asia (i.e. Sri Lanka, Bangladesh, Nepal, Pakistan) ensures that all activities performed in the assigned region under responsbility of HOYA Surgical Optics, comply with the applicable regulations. This person is primary responsible for compliance with national regulations for the Indian and South Asia countries organization and for complaint handling and post market activities in those regions.
The QA manager acts as Internal and supplier auditor for Internal HOYA’s sites, Suppliers and Distributors.
Key Duties & Responsibilities
- Establishes, implements, and maintains a Quality Management System (QMS) to meet the requirements of ISO 13485 standards as well as India and South Asia regulations applicable for a license holder company in India
- Oversees and ensures that activities performed by HOYA in India and South Asia, comply with local regulations and the applicable parts of the HOYA Global Quality Management System
- Supervises, monitors, and instructs distributors in India and South Asia regarding compliance to product related Hoya’s and regulatory requirements, post-market surveillance processes and Good Distribution Practice. Conducts trainings regarding customer complaint management and reportability of adverse events and creates necessary awareness
- Oversees and ensures that distributors working for HOYA in India, and South Asia are meeting local regulations and comply with the requirements set out in the relevant Distributor Quality Agreement
- Responsible for adequate and effective relationship management with distributors, regulators, the HOYA India and other HOYA regional teams, including operations, R&D, GHQ
- Ensures that reportable adverse events and the post-market surveillance activities in compliance with all response countries regulation requirement, no limited to AE monitoring, recall, FSCA, and post periodic risk evaluation report
- Trains employees/distributors/suppliers in region about applicable regulations and quality system requirement to raise awareness on regulatory and quality compliance
- Responsible for ongoing compliance of the Quality Management Systems and business practices with the applicable regulations by highlighting and implementing regulatory requirements, driving improvement initiatives, and where necessary escalating issues to Senior Management
- Qualified and act as lead auditor for Internal and Distributor audits for Hoya sites, Distributors or Suppliers
- Ensures timely complaint register/transfer through Hoya Feedback Network, return of complaint samples, as well as effective customer communication on complaints.
- Primary liaison for complaints and product quality related issues as well as field action in India, and south Asia
- Supports the business in solving issues with customers and distributors that relate to product quality
- Bachelor’s degree in a technical discipline required or comparable education
- 5 - 10 years of experience in management of quality systems in a regulated environment
- Familiarity with ISO 13485/ medical device is required
- Experience with working with counterparts in other Asian countries is preferred
- People skills, project management skills (both written and oral), budgeting skills and analytical skills that demonstrate the ability to recognize when system or staff adjustments are needed
- Possession of a good sense of supply chain and distribution is a plus
- Ability to communicate technical medical device information
- Proficient at process mapping, flowcharting, database systems, Excel spreadsheet, and Microsoft Office
- Able to speak and write fluently in English
- Up to 10%, mainly throughout Asia
We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.